Documents FAQs

Answers to some of the most frequently asked questions (FAQs) about working with documents in SiteVault.

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General

• Why should I manage all document versions, including previous versions, in SiteVault?

  SiteVault automatically maintains version control so that teams can be confident that they’re working and collaborating on the current version of a document, while also maintaining access to previous versions.

  Document versioning is useful in a number of ways, for example, when a document requires changes or when you need to resolve monitor feedback. SiteVault stacks the new version of the document on top of the previous version so that you can easily view all versions in one place. You can even compare the versions to see the differences.

  When you create a new approved version of a previously approved document (such as updating a 1.0 document to a 2.0 version), SiteVault automatically updates the status of the previously approved version to Superseded. Although the older version remains in the system, you can no longer edit the document.

• What's the difference between the Library and eBinder?

  The Documents > Library tab displays all documents that you have access to in SiteVault regardless of lifecycle state, for example, Draft, Current, or Superseded. When you upload a document, the document is uploaded to the document library rather than to an eBinder folder. Once you move the document to its steady state (such as Current or Final), the document is automatically filed to your study eBinder. Where the document is filed in the eBinder is determined by the document type. You can also upload directly into the eBinder either by selecting the eBinder Upload button or using your cursor to drag a local document into an eBinder folder.

  See the Study eBinder & Document Library page for more information.

• How do I send training logs to a sponsor?

  Complete the following steps to send training logs to a sponsor:

  1. Navigate to the Reporting > Reports tab, and open the Training Material Report by Study (Training Log) report.
  2. Select the study in the dialog box, then select Continue.
  3. Select Export to PDF from the actions menu (...) of the report.
  4. Upload the exported report as a document of type Training Evidence (study-specific), and change the state of the document to Final.
  5. Send the report to your sponsor. If your study is a Connected Study, see the Study Connect section for information on sending the document directly to the sponsor or CRO from SiteVault.
• Why is my document not displayed in the eBinder?

  If your document isn’t displayed in the study eBinder, you can use the following list to troubleshoot any possible issues:

  • Ensure that the document is in its steady or final state. Only steady-state documents are displayed in the eBinder.
  • Ensure that the study is selected in the Study Selector.
  • Ensure that you are looking in the correct section of the eBinder.
  • If the document is a profile document for a study team member, ensure that the person is assigned to the study in an Active state.
  • If the document is a profile document for an organization, ensure that the organization is added to the study as a partner organization in an Active state.
• Why can't I edit the document types or eBinder structure?

  Sites from all over the world use SiteVault, so standardization ensures that all sites can use SiteVault efficiently and effectively. At your site, this standardization provides consistent eBinder structure and study documents across all your studies, regardless of the sponsor. Using a standard folder structure helps all SiteVault users quickly find documents and identify any missing documents. The standard structure also facilitates the automatic filing of documents in SiteVault, which greatly decreases your administrative burden.

  If you have questions about where a document is filed in the eBinder, use the eBinder Quick Reference Card. This resource shows where particular document types are filed in the eBinder. You can also use the Document Types Reference Spreadsheet. This resource covers all of the document types available in SiteVault and includes descriptions and other important information for each document type.

  We’re always looking for feedback and recommend letting our product team know whether additional eBinder folders or document types are needed. The more feedback you provide, the greater likelihood of us adopting the feedback, especially when the same feedback comes from multiple sites.

• Why can't I redact documents in SiteVault?

  SiteVault is HIPAA-compliant and capable of storing unredacted documents. For source documents, SiteVault does prompt you to select whether the uploaded document has redactions.

  Our sponsor partners prefer that documents remain unredacted to perform source document verification effectively. When documents are redacted, it’s more difficult to perform source data verification or monitor review. Note that external users such as monitors or CRAs cannot download source documents.

  We encourage you to follow your site’s SOPs regarding redactions in SiteVault while also consulting the trial agreements with the sponsor or CRO for any study-specific requirements.

Creating Documents

• How do I upload source documents?

  See the Managing Source Documents for Remote Monitoring page to learn how to upload source documents.

• How do I upload regulatory documents?

  See the Managing Study Documents page to learn how to upload regulatory documents.

• How do I create an eConsent form?

  See the Managing eConsent Forms page to learn how to create and edit eConsent forms.

• Why should I complete all of the document fields when uploading documents?

  While you can upload documents without completing all of the fields, completed fields make your information and documents in SiteVault searchable and retrievable. Completing the fields enables you to leverage the full range of SiteVault’s capabilities, including automatic filing, automatic naming, profile documents, filters in the document library and eBinder, advanced search options to search content and metadata, and automatic reporting and dashboards.

• Why can't I upload documents in a non-Draft state, for example, Current, Final, or Approved for Use?

  Using SiteVault to process a document from a draft to final or approved state enables you to take full advantage of SiteVault’s capabilities as an eRegulatory solution.

  How you create and finalize a document in SiteVault depends on the document type and its associated lifecycle. In general, directly changing the state to approved should be used for electronically received documents and identifies the document as an original. The eSignature workflow automatically changes the state to approved once the document is signed. The Certify as Copy workflow should be used for scanned paper copies.

Finalizing Documents

• How do I finalize documents?

  Finalizing a document moves it to its final (steady state) and creates a major version of the document (for example, 1.0 or 2.0). The workflow to finalize a document depends on the document type and its lifecycle. See the Document Types Reference Spreadsheet for information on the types of documents in SiteVault and their associated lifecycles. Depending on the category of document, see the following help to learn more about how to finalize a document:

  • Finalizing Legal and Financial Documents
  • Finalizing Profile Documents
  • Finalizing Source Documents
  • Finalizing Study Documents
• Why should I certify documents as a copy?

  When you upload a document to SiteVault, the document is uploaded as a Draft version and you must move the document to its steady state (such as Final or Approved for Use) before it’s considered final and filed to your study’s eBinder.

  Certifying the document as a copy finalizes the document while recognizing that it's a paper scan and is now considered the original.

• Why can't I approve documents in bulk?
  Bulk approval would compromise the integrity of the approval process, as individually approving documents ensures that you're maintaining regulatory compliance over each document.
• Why can't I use eSignature on all documents?

  Because of regulatory requirements, only a limited number of documents can be sent for electronic signature in SiteVault. We’re working to expand the list of eligible documents. You can use the Document Types Reference Spreadsheet to see which documents are currently available to be electronically signed.

  When a document is signed electronically, SiteVault creates a separate eSignature page, because the signature can’t be placed in a specific location on the document. Typically, only one person can electronically sign a document; however, multiple people can sign an eConsent form if needed.

Editing and Deleting Documents

• How do I edit documents in SiteVault?

  SiteVault has several features that enable you to edit documents and facilitate real-time collaboration. The following features a few for you to consider:

  • The annotate tool enables you to leave a comment on a document that other users can see.
  • You can check out documents to make edits. The checked out document is downloaded to your computer where you can make edits and check back in when finished. SiteVault automatically upversions the document for you.
  • With the version compare feature, you can compare versions of a document to see what changes were made between the two versions.
• How do I delete documents?

  See the following help for information on how to delete documents:

  • Deleting Draft Documents: Learn how to delete documents that are in the Draft state.
  • Deleting Steady-State Documents: For Site Administrator users, learn how to delete all versions of a steady-state or major version document, for example, a Current, Final, or Approved for Use document.

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Overview of Documents

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Study eBinder & Document Library

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Related Help

• Overview of Documents
• Deleting Steady-State Documents
• Study eBinder & Document Library
• Using eSignatures